NL-OMON52552已完成不适用
A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Prostate Specific Membrane Antigen (PSMA) Half Life Extended (HLE) Bispecific T-cell Engager (BiTE) AMG 160 in Subjects With Metastatic Castration Resistant Prostate Cancer (mCRPC) - 20180101
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 17
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Age >= 18 years at the time of signing the informed consent
- •- Subjects with histologically or cytologically confirmed mCRPC who are
- •refractory to a novel antiandrogen therapy (abiraterone, enzalutamide, and/or
- •apalutamide) and have failed at least 1 (but not more than 2) taxane regimens
- •(or who are deemed medically unsuitable to be treated with a taxane regimen or
- •have actively refused treatment with a taxane regimen). Progression on novel
- •antiandrogen therapy may have occurred in the non-metastatic CRPC setting.
- •- Expansion cohort 1b only: maximum of 3 systemic therapies administered in any
- •prostate cancer disease setting (including chemotherapy, systemic radiotherapy,
- •novel hormonal, or investigational therapies, but not including ADT or bone
- •targeted therapies)
- •- Expansion cohort 1b only: subjects with baseline PSMA-positive disease
- •assessed by PSMA PET scan (central assessment)
- •- Subjects must have undergone bilateral orchiectomy or must be on continuous
- •ADT with a gonadotropin releasing hormone (GnRH) agonist or antagonist
- •- Total serum testosterone <= 50 ng/dL or 1.7 nmol/L
- •- Evidence of progressive disease, defined as 1 or more PCWG3 criteria:
- •PSA level >= 1 ng/mL that has increased on at least 2 successive occasions at
- •least 1 week apart
- •nodal or visceral progression as defined by RECIST 1.1 with PCGW3
- •modifications
- •appearance of 2 or more new lesions in bone scan
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Please see section 6.1 of the protocol.
排除标准
- •- Pathological finding consistent with pure small cell, neuroendocrine
- •carcinoma of the prostate or any other histology different from adenocarcinoma
- •- Radiation therapy within 4 weeks of first dose (or local or focal
- •radiotherapy within 2 weeks of first dose)
- •- Central nervous system (CNS) metastases, leptomeningeal disease, or spinal
- •cord compression
- •- Prior major surgery within 4 weeks of first dose
- •- Active autoimmune disease or any other diseases requiring immunosuppressive
- •therapy while on study
- •- Presence of fungal, bacterial, viral, or other infection requiring IV
- •antimicrobials for management within 7 days of dosing
- •NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis
- •are permitted if responding to active treatment and after consultation with
- •sponsor. Screening for chronic infectious conditions is not required.
- •- History of arterial or venous thrombosis (eg, stroke, transient ischemic
- •attack, pulmonary embolism or deep vein trombosis) within 12 months of first
- •dose of AMG 160
- •- Symptomatic peripheral sensory or motor neuropathy of grade >= 3
- •- History or presence of clinically relevant CNS pathology as uncontrolled
- •epilepsy or seizure disorder, paresis, aphasia, stroke, severe brain injuries,
- •dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, and
- •- Myocardial infarction, unstable angina, cardia arrhythmia requiring
- •medication, and/or symptomatic congestive heart failure (New York Heart
- •Association > class II) within 12 months of first dose of AMG 160
- •- Unresolved toxicities from prior anti-tumor therapy not having resolved to
- •Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1,
- •with the exception of alopecia or toxicities that are stable and
- •well-controlled AND there is agreement to allow by both the investigator and
- •- History of other malignancy within the past 2 years, with the following
- •exception(s):
- •malignancy treated with curative intent and with no known active disease
- •present for >= 2 years before enrollment and felt to be at low risk for
- •recurrence by the treating physician
- •adequately treated non-melanoma skin cancer or lentigo maligna without
- •evidence of disease
- •adequately treated urothelial papillary noninvasive carcinoma or carcinoma in
- •- History or evidence of gastrointestinal inflammatory bowel disease
- •(ulcerative colitis or Crohn disease) or any other gastrointestinal disorder
- •causing chronic nausea, vomiting, or diarrhea (defined as >= 2 CTCAE grade 2)
- •- Prior PSMA-targeted therapy (subjects on prior PSMA radionuclide therapy may
- •be eligible if discussed with Amgen medical monitor prior to enrollment)
- •NOTE: subject cannot have received PSMA radionuclide therapy < 35 days prior to
- •enrollment if subject received < 2 cycles therapy; for each additional cycle of
- •therapy, an additional 30 days are required for wash out)
- •- Any anticancer therapy or immunotherapy within 4 weeks of start of first
- •dose, not including LHRH/GnRH analogue (agonist/antagonist). Subjects on a
- •stable bisphosphonate or denosumab regimen for >= 30 days prior to enrollment
- •are eligible
- •- Needing chronic systemic corticosteroid therapy (prednisone dose > 10 mg per
- •day or equivalent) or any other immunosuppressive therapies (including
研究者
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